Aditx Therapeutics(ADTX) - 2024 Q3 - Quarterly Report

Company Overview - Adimune, Inc. is focused on immune modulation therapeutic programs, with its product candidate ADI-100 successfully tested in preclinical models for conditions like psoriasis and type 1 diabetes[169]. - Pearsanta, Inc. aims to revolutionize personalized medicine with a platform for lab-quality testing, targeting a clinical and consumer diagnostic market projected to reach $429.3 billion by 2030[172]. Product Development - A clinical trial for ADI-100 targeting Stiff Person Syndrome is expected to begin in the first half of 2025, pending approval, with an initial enrollment of up to 20 patients[169]. - The Mitomic® Technology Platform acquired from MDNA is designed for non-invasive disease detection through mitochondrial DNA analysis, enhancing early diagnosis and treatment[172]. - The Mitomic® Endometriosis Test (MET™) aims to provide accurate, non-invasive diagnosis, potentially reducing the diagnostic delay of around ten years for endometriosis[172]. - The Mitomic® Prostate Test (MPT™) seeks to improve detection of clinically significant prostate cancer, reducing reliance on PSA testing and minimizing unnecessary procedures[174]. - AditxtScore technology offers a personalized immune system profile, enabling detection of immune responses to various agents, with rapid and accurate assays[176]. - The AditxtScore technology features a 20-fold higher dynamic range compared to conventional assays, enhancing sensitivity and specificity[177]. - A license agreement with Loma Linda University grants exclusive rights to commercialize ADI nucleic acid-based technology, currently in the pre-clinical stage[171]. - An exclusive license agreement with Stanford University secures worldwide exclusivity for the patented technology used in AditxtScore, enhancing the company's competitive position[178]. Financial Performance - For the three months ended September 30, 2024, the company generated revenue of $6,854, a decrease of 94.5% compared to $124,486 for the same period in 2023[184]. - The company incurred a net loss of $29,472,886 for the nine months ended September 30, 2024, compared to a loss of $18,111,541 for the same period in 2023, indicating a significant increase in losses[182][184]. - As of September 30, 2024, the company had an accumulated deficit of $162,867,941 and working capital of $(22,280,585)[182]. - Research and development expenses for the nine months ended September 30, 2024, were $10,190,178, which included $6,712,663 in stock-based compensation[184]. - The company expects to incur additional net expenses over the next several years as it continues to maintain and expand its operations[182]. - The company raised approximately $9 million from a private placement in September 2023, which was used for outstanding obligations and working capital[186]. - The company entered into a securities purchase agreement in December 2023, resulting in net proceeds of approximately $5.5 million for working capital and obligations[186]. - The company has not generated significant revenues to date and requires substantial additional capital to fund operations and clinical studies[181][190]. - The company generated revenue of $130,810 for the nine months ended September 30, 2024, a decrease of 76.8% compared to $563,879 for the same period in 2023[184]. Going Concern and Compliance - The company is currently over 90 days past due on a significant number of vendor obligations, raising concerns about its ability to continue as a going concern[181]. - The company is classified as an "emerging growth company" and intends to rely on exemptions under the JOBS Act until it meets certain revenue or debt thresholds[193]. - The company will remain an "emerging growth company" until it has total annual gross revenues of $1.07 billion or more or until December 31, 2025, whichever comes first[193]. - The company is evaluating the benefits of relying on reduced reporting requirements provided by the JOBS Act[193]. - There are no off-balance sheet arrangements currently or during the periods presented[192]. - The company is not required to provide market risk disclosures as it qualifies as a "smaller reporting company" under the Exchange Act[197].